Human error and systems failure caused IVF mix up
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《英国医生杂志》
A combination of "inadvertent human error and systems failure" caused a mix up in in vitro fertilisation (IVF) treatment that led to the birth of mixed race twins to a white couple in the north of England, an official report concluded this week.
An investigation commissioned by the Department of Health made more than 100 recommendations to tighten up procedures governing the provision of infertility services, in a report that criticises the government and the Human Fertilisation and Embryology Authority, which regulates clinics.
The inquiry, led by Professor Brian Toft, was set up in July 2002 after four mishaps at two clinics run by the Leeds Teaching Hospitals NHS Trust. In one case two sets of sperm samples were mixed up, leading to the birth of the mixed race twins.
The birth was followed by a high court case to decide the twins?legal parentage. In February 2003 Elizabeth Butler-Sloss, president of the High Court抯 family division, ruled that their black biological father was also their legal father, although the twins remained with the white couple.
Another case of mistakenly identified sperm was spotted in time. Other incidents involved the accidental discarding of embryos and the loss of embryos that had not been properly frozen.
Professor Toft, a specialist in risk management, said confidentiality requirements had led to a "culture of secrecy" that had had a prejudicial effect on the authority抯 ability to carry out its duties in an open and effective way. Furthermore, the government had failed to provide the funds it needed to be an effective regulator.
The report identified a number of failures in the authority抯 management and inspection regime and staff shortages and poor facilities at the Leeds clinics.
"Patients need to be confident in the assisted conception treatments they are receiving," said Professor Toft. "During this review we identified a number of potential vulnerabilities and weaknesses in the regulatory procedures and clinical systems that were in place when the incidents occurred."
He pointed out that the authority抯 funding had remained virtually the same in real terms since its founding in 1990, while the number of clinics under its aegis had rapidly expanded. The result was a "less robust" inspection regime focusing on clinics at higher risk.
Professor Toft said he recognised that the events occurred before July 2002 and that both the authority and the Leeds trust had been addressing the concerns.
The health department accepted that the authority should be funded properly and its resources regularly reviewed. Liam Donaldson, the chief medical officer, said: "Lessons will be learnt from what happened so that we can reduce the chance that anything like this will happen again."
The authority said it had already implemented 85% of Professor Toft抯 recommendations, including double checking of identification of patients at all stages of treatment, unannounced inspections of clinics, improved recruitment and training of inspectors and staff, and an alert system for untoward incidents. A new code of practice for clinics had also been introduced.
The authority抯 chairwoman, Suzi Leather, said: "This mistake has caused great emotional turmoil and pain. We owe it to every patient and every baby born to make sure that the authority is doing everything possible to minimise the risks."(BMJ Clare Dyer legal corr)
An investigation commissioned by the Department of Health made more than 100 recommendations to tighten up procedures governing the provision of infertility services, in a report that criticises the government and the Human Fertilisation and Embryology Authority, which regulates clinics.
The inquiry, led by Professor Brian Toft, was set up in July 2002 after four mishaps at two clinics run by the Leeds Teaching Hospitals NHS Trust. In one case two sets of sperm samples were mixed up, leading to the birth of the mixed race twins.
The birth was followed by a high court case to decide the twins?legal parentage. In February 2003 Elizabeth Butler-Sloss, president of the High Court抯 family division, ruled that their black biological father was also their legal father, although the twins remained with the white couple.
Another case of mistakenly identified sperm was spotted in time. Other incidents involved the accidental discarding of embryos and the loss of embryos that had not been properly frozen.
Professor Toft, a specialist in risk management, said confidentiality requirements had led to a "culture of secrecy" that had had a prejudicial effect on the authority抯 ability to carry out its duties in an open and effective way. Furthermore, the government had failed to provide the funds it needed to be an effective regulator.
The report identified a number of failures in the authority抯 management and inspection regime and staff shortages and poor facilities at the Leeds clinics.
"Patients need to be confident in the assisted conception treatments they are receiving," said Professor Toft. "During this review we identified a number of potential vulnerabilities and weaknesses in the regulatory procedures and clinical systems that were in place when the incidents occurred."
He pointed out that the authority抯 funding had remained virtually the same in real terms since its founding in 1990, while the number of clinics under its aegis had rapidly expanded. The result was a "less robust" inspection regime focusing on clinics at higher risk.
Professor Toft said he recognised that the events occurred before July 2002 and that both the authority and the Leeds trust had been addressing the concerns.
The health department accepted that the authority should be funded properly and its resources regularly reviewed. Liam Donaldson, the chief medical officer, said: "Lessons will be learnt from what happened so that we can reduce the chance that anything like this will happen again."
The authority said it had already implemented 85% of Professor Toft抯 recommendations, including double checking of identification of patients at all stages of treatment, unannounced inspections of clinics, improved recruitment and training of inspectors and staff, and an alert system for untoward incidents. A new code of practice for clinics had also been introduced.
The authority抯 chairwoman, Suzi Leather, said: "This mistake has caused great emotional turmoil and pain. We owe it to every patient and every baby born to make sure that the authority is doing everything possible to minimise the risks."(BMJ Clare Dyer legal corr)